Status
Terminated
Drug Enforcement D-037-2013
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Classification
Class I
Report Date
November 7, 2012
Termination Date
November 30, 2015
Product Information
- Product description
- X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
- Product quantity
- 215,000 capsules
- Reason for recall
- Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
Location & Firm
- Recalling firm
- XRock Industries, LLC
- Address
-
571 Se 14th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-037-2013
- Event ID
- 61669
- Recall initiation date
- April 21, 2012
- Center classification date
- November 1, 2012
- Code info
- UPC 0 00309 50792 7 All Lots
- More code info
- —